Hormone Replacement Therapy Litigation

Hormone replacement therapy (HRT) is used by a large number of women over 50 to relieve the symptoms of menopause. For the insurance industry the principle concern revolves around the potential for class actions by HRT users against HRT manufacturers and the associated potential for liability under General and Product Liability policies.

When HRT emerged in the 1940's it was used as an effective method to combat the sometimes debilitating symptoms of menopause that typically affect women aged 50 and over. In the 1960's popularity of HRT as a treatment boomed and was claimed to additionally reduce the risk of many other diseases. It appeared that manufacturers had developed a wonder drug for women. However, concerns and evidence came to light indicating that the perceived benefits either did not exist or that HRT increased the risk of certain diseases.

Legal challenges

Several legal actions have been taken against pharmaceutical companies. Compensatory and punitive damages have been awarded, though many are on appeal. The current trend is for the plaintiff (those seeking compensation) to argue that taking HRT resulted in their developing breast cancer later in life. They also claim to have been misled by advertising claiming real benefits that later turned out to be false.

Counter arguments for the defendant are typically that they included adequate information about the risks associated with the drug and complied with regulatory requirements. In addition, arguments centre on the difficulty in making a causal link between HRT and developing cancer as there are many other risk factors at play.

Causation

Legal cases to date have highlighted that it is challenging to prove that HRT was the leading cause for developing breast cancer when so many other factors contribute to cancer risk, such as genetic susceptibility, sun exposure and smoking.

Another key issue is whether manufacturers have been misleading with regards to their promotional material, or were simply reflecting the current knowledge of the day.

Key risks to HRT users

HRT has been shown to alter the risk of some cancers and cardiovascular diseases. Depending upon certain risk factors there is an increased risk of developing stroke, venous thromboembolism, breast cancer, ovarian cancer and endometrial cancer.

Legal Cases to date

The majority of law suits are US based and involve women suing the pharmaceutical company Wyeth for personal injury. Wyeth is a large manufacturer of several HRT products including Prempro and Premarin, and the women claim that these products caused their development of breast cancer. Wyeth is not the sole manufacturer of HRT, though according to a review article in the British Medical Journal, in 2003 Wyeth had more than a 70% share of the global market.

As of December 2007 Wyeth faces 5,400 actions brought on behalf of 7,900 women and several presented here are acting as test cases. The following cases have been brought in Pennsylvania, New Jersey, Arkansas, Florida and Nevada. The American Tort Reform Association place South Florida, New Jersey and Nevada in their top 6 places in the US that are considered to be aggressive against defendants in civil lawsuits such as those against HRT manufacturers.

Conclusions

Research carried out over the last decade has identified and evaluated the risks associated with HRT. It has been shown to increase the risk of several diseases. Nevertheless, it is still deemed suitable for treating women with severe symptoms of the menopause with the advice of their doctor.

The biggest concern lies in the effect of HRT on the development of breast cancer due to the combination of several factors including:

As far as we are aware there is no definitive method to prove that taking HRT caused an individual person to develop a disease. However this has not stopped damages being awarded to women seeking to sue manufacturers for compensation due to the increased susceptibility caused by using HRT.

The majority of legal cases are waiting for the outcome of the current test cases, and several routes are being tried that include legal action based on:

Insufficient or misleading labeling or advertising;

Attempting to claim for medical monitoring costs; and

Neglect in duty of care to fully investigate risks of the drug before sending to market.